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Session 4: Innovative Approaches and Considerations for Use of External Controls in Drug Development
Session Chair(s)
Gillis Carrigan, PhD, MS
Director, Center for Observational Research, Amgen, United States
This session will explore the current state of external controls for use in drug development. Specifically, the session opens with an overview of the history and evolving use of external controls, a case study, considerations around selection of appropriate data sources and concludes with an exploration of AI derived digital twin for use as external controls. The session will provide current state information selected from this exciting and evolving area of drug development science.
Speaker(s)
Representative Invited
Senior Director, Datavant, United States
Externally Controlled Trials Using Real-World Data: Adapting SPIFD2 to Ensure Principled Design and Data Selection (SPIFD-ECT)
Bernat Navarro, PhD
Senior Science Policy Analyst, Friends of Cancer Research, United States
Advancing External Control Arms for Regulatory Use: Lessons from a Multi-Stakeholder Pilot
Daniele Bertolini, PhD, MS
Principal Machine Learning Scientist, Unlearn.AI, United States
Digital Twins